EscharEx (EX-02) for small superficial and nodular basal cell carcinoma.

An Open-Label Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma

The trial will try topical EscharEx (EX-02) on adults with small (5–10 mm) superficial or nodular basal cell carcinomas on the trunk or upper arms to see if it safely clears the tumor.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: MediWound Ltd (industry)
• Drugs / interventions: radiation
• Locations: 3 sites (Aventura, Florida and 2 other locations)
• Trial ID: NCT05157763 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, one-arm study will enroll 32 adults with a single histologically confirmed superficial or nodular basal cell carcinoma (5–10 mm) on the trunk or upper extremities. All participants will receive topical EscharEx (EX-02) 5% in two sequential cohorts (first 16 patients for initial safety review, then 16 additional patients) with frequent clinic visits during the treatment period. Patients will undergo complete surgical excision about eight weeks after treatment and will be followed until biopsy confirms tumor clearance and the wound has closed. Safety monitoring includes sponsor review and oversight by a DSMB, and primary endpoints include safety and histologic lesion clearance.

Who should consider this trial

Good fit: Adults (≥18 years) with one histologically confirmed superficial or nodular BCC measuring 5–10 mm on the trunk or upper extremities, with well-defined borders and no prior radiation to the site, are ideal candidates.

Not a fit: Patients with larger lesions, morphea-type or high-risk BCCs, multiple lesions, lesions on the hands, metastatic disease, Gorlin syndrome, or other non-BCC skin cancers at the site are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, EscharEx could provide a non-surgical topical option to clear small superficial or nodular BCCs and potentially reduce the need for immediate excision and scarring.

How similar studies have performed: Enzymatic eschar-debridement products have established uses in wound care, but using an EscharEx formulation specifically to treat BCC is a novel approach with limited published clinical evidence to date.

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria- Patient level

1. Male or female greater than age 18,
2. Patients with one primary superficial or nodular basal cell carcinoma lesion (Histologically confirmed BCC) located on the trunk or upper extremities (not including the hands), with well-defined borders and no previous radiation therapy.
3. Lesion is present for no longer than 4 years.
4. Lesion with a diameter of 5-10mm,
5. Patient and/or legally authorized representative (LAR) understands the nature of the procedure, is able and willing to adhere to the protocol regimen, and able to provide a written informed consent prior to any study procedure.

Exclusion Criteria:

Exclusion Criteria- Patient level

1. Evidence of Gorlin syndrome, neoplastic diseases (except actinic lesions), metastatic tumor or tumor with high probability of metastatic spread,
2. Other malignant cancers (non BCC) of the skin at the lesion's site,
3. Morphea-type basal cell carcinoma (MBCC) at the lesion's site (per biopsy report),
4. Any signs of infection at the lesion site including purulent discharge, tissue abscess, erysipelas, cellulitis, etc.,
5. Patients with any dermatological disease in the target lesion site or surrounding area (not including chronic actinic damage in the surrounding area),
6. History of allergy or atopic disease or a known sensitivity to pineapples, papaya, bromelain or papain, as well as known sensitivity to latex proteins (known as latex-fruit syndrome), bee venom or olive tree pollen,
7. Patients undergoing renal or peritoneal dialysis,
8. Any condition that would preclude safe participation in the study, e.g. evidence of significant or unstable cardiovascular, pulmonary, liver, hematological, immunological, or any immediate life threatening condition,
9. Concurrent acute injury or disease that might compromise the patient's welfare or the participation in the study,
10. Current (within last 12 months) severe alcohol or drug use disorder
11. Pregnant women (positive blood or urine pregnancy test) or nursing mothers,
12. Exposure to investigational intervention within 4 weeks prior to enrolment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study.

Where this trial is running

Aventura, Florida and 2 other locations

• Center for Clinical and Cosmetic Research — Aventura, Florida, United States (RECRUITING)
• Moore Clinical Research, Inc. — Brandon, Florida, United States (NOT_YET_RECRUITING)
• Center for Clinical Studies, LTD. LLP — Webster, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Limor Dinur Klein, PhD

Conditions: Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma